Is a device with the capability to suture endoscopically a valuable tool for a variety of endolumenal GI procedures? Is the 510(k) clearance of the OverStitch endoscopic suture system a significant step towards making the benefits of endolumenal surgery a realistic therapeutic option? Will the OverStitch system will enable the advanced endoscopist to perform more aggressive procedures such as EMR and full thickness resection?
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…Apollo Endosurgery Inc. announced today that the FDA has cleared a 510(k) application to market its OverStitch(TM) endoscopic suture system. This allowance opens the way for US
commercial release of the product, which is anticipated for late 2008.The OverStitch system is a single-use device that fits onto standard flexible endoscopes and enables physicians to place full thickness running or interrupted sutures into targeted tissues…
The OverStitch endoscopic suture system is a fully disposable suturing system that allows a physician to use a standard flexible endoscope to place sutures. The device quickly mounts to common therapeutic endoscopes and is designed to safely navigate through delicate areas of the anatomy. Once at the urgical site, custom needle-suture sets — available with standard absorbable and non-absorbable materials up to 2-0 in thickness — can be loaded and reloaded without removing the device or the endoscope. The physician can then place either an interrupted or running stitch, which can be secured with an included cinching device or by using the device itself to tie a surgical knot…
Apollo Endosurgery, Inc. develops and markets medical devices for minimally invasive surgical procedures conducted through natural orifices. These minimally invasive procedures are at the convergence of flexible endoscopy and general surgery, and include procedures inside the gastrointestinal tract (endolumenal surgery) as well as procedures that cross the lumen to the peritoneal cavity (known as translumenal surgery, or NOTES). Using a new class of Apollo’s proprietary flexible access devices and surgical tools, surgeons and gastroenterologists will be able to perform scarless interventions for the treatment of early stage cancers, obesity, and general surgical procedures in the peritoneal cavity. In addition to avoiding the scars caused by abdominal incisions, these procedures are expected to result in less pain, require less sedation, and lead to faster recovery times. Apollo Endosurgery was cofounded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the University of Texas Medical Branch, and the Chinese University of Hong Kong. The company is funded by PTV Sciences and H.I.G Ventures.